The PROBEAT-V with X-ray Limiting Accessory is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Device Description

The PROBEAT-V with X-ray Limiting Accessory is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

The X-ray Beam Limiting accessory for use in conjunction with the cleared PROBEAT-V system is designed to limit the patient's X-ray exposure during for patient positioning with the Cone Beam CT (CBCT). The device has 4 motorized leaves which are controlled by the PROBEAT-V imaging software to position the leaves in order to limit the patient's radiation exposure during patient positioning.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and detailed performance data on the X-ray Limiting Accessory itself.

Based on the provided information, I can extract the following:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that "In all cases, the device performed as intended and met all pre-specified success criteria." The performance evaluation focused on the integration of the X-ray Beam Limiting Device with the PROBEAT-V system.

Acceptance Criteria Category	Reported Device Performance
Slice Pitch Accuracy	Met all pre-specified success criteria and performed as intended.
Spatial Accuracy	Met all pre-specified success criteria and performed as intended.
Spatial Resolution	Met all pre-specified success criteria and performed as intended.
Isocenter Accuracy	Met all pre-specified success criteria and performed as intended.
Performance with Proton Beam Therapy Positioning System	Met all pre-specified success criteria and performed as intended.
Electrical Safety	Evaluated and met all pre-specified success criteria and performed as intended.
Electromagnetic Compatibility	Performed and met all pre-specified success criteria and performed as intended.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the test set or data provenance (country of origin, retrospective/prospective). The testing appears to be a validation of the integrated system in an engineering and performance testing context rather than a clinical study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The testing described appears to be technical performance testing of the device itself (e.g., accuracy, resolution, safety) and not a diagnostic or therapeutic output requiring interpretation by medical experts to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing described appears to be technical performance testing of the device itself and not a diagnostic or therapeutic output requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a proton beam therapy system with an X-ray limiting accessory, not an AI-based diagnostic or therapeutic assistance system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device's X-ray limiting accessory and its integration with the PROBEAT-V system. The "Performance Data" section describes this standalone performance testing for the integrated system, including slice pitch accuracy, spatial accuracy, spatial resolution, isocenter accuracy, and performance with the proton beam therapy positioning system, as well as electrical safety and electromagnetic compatibility. The device performed as intended and met all pre-specified success criteria in these tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance tests mentioned (slice pitch accuracy, spatial accuracy, etc.), the "ground truth" would be established by validated measurement standards and reference devices used in engineering and quality control, rather than clinical ground truth like pathology or expert consensus. For electrical safety and electromagnetic compatibility, the ground truth would be compliance with relevant international and national standards.

8. The sample size for the training set

Not applicable for this type of device and submission. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable for this type of device and submission. This is not an AI/machine learning device requiring a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 13, 2016

Hitachi, Ltd. % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016

Re: K161163

Trade/Device Name: PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: April 25, 2016 Received: April 25, 2016

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K161163

Device Name

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

Indications for Use (Describe)

The PROBEAT-V with X-ray Limiting Accessory is a medical devices designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hitachi, Ltd. 2-16-1 Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan Telephone: +81 (3) 62843741 Facsimile: +81 (3) 62843657

Contact Person: Naoya Nishimura

Date Prepared: June 30, 2016

Name of Device and Name/Address of Sponsor

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

Hitachi, Ltd. Healthcare, Hitachi Works 3-1-1 Saiwai-cho, Hitachi-shi, Ibaraki-ken, 317-8511 Japan

Common or Usual Name

Accessory to proton beam therapy system

Classification Name

Medical Charged-Particle Radiation Therapy System, 21 C.F.R. § 892.5050, Product Code LHN

Predicate Devices

PROBEAT-V (K152592)

Intended Use / Indications for Use

Technological Characteristics

The PROBEAT-V with X-ray Limiting Accessory is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton

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beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

Performance Data

Testing was performed to evaluate that the integration of the X-ray Beam Limiting Device with the previously cleared PROBEAT-V does not impact the performance of the system. This testing evaluated slice pitch accuracy, spatial accuracy, spatial resolution, and isocenter accuracy as well as testing with the proton beam therapy positioning system. Electrical safety was evaluated and electromagnetic compatibility testing was performed with the integrated system. In all cases, the device performed as intended and met all pre-specified success criteria.

Substantial Equivalence

The PROBEAT-V with integrated X-ray beam limiting device accessory for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation is substantially equivalent to the cleared PROBEAT-V system. Both the current and cleared devices have the exact same intended use and substantially similar indications for use and technological characteristics. The addition of the X-ray beam limiting accessory to the system does not alter the intended therapeutic effect of the device system, and does not raise new or different questions of safety or efficacy. The addition of this accessory simply allows for minimizing radiation exposure during image acquisition and patient positioning. Thus, the PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is substantially equivalent to its predicate.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.